Bauer, Taub, and Parsi's review of an international sample of standards on informed consent, confidentiality, commercialization, and quality of research in tissue banking reveals that no clear national or international consensus exists for these issues. The authors' response to the lack of uniformity in the meaning, scope, and ethical significance of the policies they examined is to call for the creation of uniform ethical guidelines. This raises questions about whether harmonization should consist of voluntary international (...) class='Hi'>standards or international regulations that include an official oversight mechanism and sanctions for noncompliance, and about who should participate in the harmonization process. Moreover, the normative assumptions and political dynamics that shape global policymaking need to be addressed. This commentary explores the policy implications and normative questions raised by the idea of international ethical guidelines for the use of biotechnologies and biotechnological resources such as stored samples of human tissue. (shrink)

ABSTRACTPeople can be moved and overwhelmed, a phenomenon typically accompanied by goose-bumps and tears. We argue that these feelings of being moved are not limited to situations that are appraise...

This research discusses the social and humanitarian grounds of measurement and assesment of innovations in the field of digital technologies based on the analysis of the international experience of the standards, in particular on the basis of the Oslo Manual issued by the Organization for Economic Cooperation and Development, which is the foundation for ISO standards. From the point of view of digitalization, an important stage in understanding innovation is the recognition of innovation not only as a (...) product, but also a process that leads to increased efficiency. Most of the tasks in the field of digital technologies are precisely related to increasing the efficiency of processes, and, consequently, digitalization is becoming an important criterion for the innovativeness of organizations. One of the purposes of digital technologies is the integration of various types of activities, therefore integrative development (including using digital platforms) is also a criterion of innovation. The digital format is unique since it allows to gain new knowledge from data analysis and processes, and therefore the analytical component, including artificial intelligence technologies, is also an indicator of innovation. The article concludes that the criteria for the innovativeness of digital technologies should include their use to improve the efficiency of organizations, to adopt communicative digital platforms, and to create a variety of data analysis tools, including artificial intelligence. (shrink)

In this book, Christian Barry and Sanjay G. Reddy propose ways in which the international trading system can support poor countries in promoting the well-being of their peoples.

Many questions arise in any Western discussion of China’s Belt and Road Initiative. Does China’s BRI represent a new world order that aligns with European values and interests? Alternatively,...

Der brasilianische Aktienmarkt, dessen Rahmenbedingungen in den Jahren 2000/2001 grundlegend umgestaltet wurden, hat danach einen beeindruckenden Aufstieg erlebt, der erst im Herbst 2008 durch die globale Finanzmarktkrise und vor allem durch den Verfall der Rohstoffpreise gestoppt wurde. Dieser Aufstieg ist Anlass genug für eine Länderstudie, die sich mit den für Brasilien maßgebenden ökonomischen Faktoren und Institutionen auseinandersetzt und dabei folgende Frage beantwortet: Welche makroökonomischen Faktoren und institutionellen Veränderungen müssen zusammentreffen, um einen lokalen Aktienmarkt im Zeitalter der Globalisierung erfolgreich zu reformieren? (...) Die Antwort wird auf der Basis einer vergleichenden Analyse jener staatlichen und privatautonomen Regelwerke entwickelt, die für den Aktienmarkt rahmenbildend sind. Dabei werden unterschiedliche Regulierungstechniken und Arrangements einander gegenübergestellt und im Hinblick auf ihre Fähigkeit bewertet, die Markteffizienz zu verbessern. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show (...) that there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

What grounds and justifies conclusions in medical ethics? Is the source external or internal to medicine? Thee influential types of answer have appeared in recent literature: an internal account, an external account, and a mixed internal / external account. The first defends an ethic derived from either the ends of medicine or professional practice standards. The second maintains that precepts in medical ethics rely upon and require justification by external standards such as those of public opinion, law, religious (...) ethics, or philosophical ethics. The third claims that distinct medical ethics have emerged from distinct cultural frameworks, each with norms that govern physicians. There is merit in each perspective, but each overreaches its supporting arguments and fails to appreciate what is legitimate in the theses of its competitors. I propose a fourth account that offers a way to escape limitations of the other three, while retaining their most attractive features. (shrink)

It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by (...) this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support. (shrink)

This book examines the labour standards provisions in a number of Regional and Bilateral Trade Agreements, and assesses the potential of using the relevant clauses in these trade agreements as a benchmark for a multilateral approach. Based on the lessons learned from the Regional model, the book proposes a Global Labour and Trade Framework Agreement (GLTFA) combined with a joint ILO/WTO enforcement mechanism to resolve the contentious issue of the link between the CLS and international trade. The history (...) of the linkage between the Core Labour Standards (CLS) and international trade dates back roughly 150 years, and has recently become one of the most vexing issues facing policy-makers. At the heart of the debate is the question whether or not trade sanctions should be imposed on countries that do not respect the CLS as embodied in multilateral conventions administered by the International Labour Organization (ILO). Concretely, this would entail inserting a social clause in the World Trade Organization (WTO) rules, and would trigger the imposition of sanctions on those countries that do not adhere to the CLS. Kofi Addo is a policy advisor to the Board of Governors of the International Baccalaureate Organisation. He holds a PhD in law from the University of Bern, Switzerland.. (shrink)

ABSTRACT:This article assesses the proliferation of international accountability standards (IAS) in the recent past. We provide a comprehensive overview about the different types of standards and discuss their role as part of a new institutional infrastructure for corporate responsibility. Based on this, it is argued that IAS can advance corporate responsibility on a global level because they contribute to the closure of some omnipresent governance gaps. IAS also improve the preparedness of an organization to give an explanation (...) and a justification to relevant stakeholders for its judgments, intentions, acts and omissions when appropriately called upon to do so. However, IAS also face a variety of problems impeding their potential to help address social and environmental issues. The contribution of the four articles in this special section is discussed in the context of standards’ problems and opportunities. The article closes by outlining a research agenda to further develop and extend the scholarly debate around IAS. (shrink)

ABSTRACT:This article assesses the proliferation of international accountability standards (IAS) in the recent past. We provide a comprehensive overview about the different types of standards and discuss their role as part of a new institutional infrastructure for corporate responsibility. Based on this, it is argued that IAS can advance corporate responsibility on a global level because they contribute to the closure of some omnipresent governance gaps. IAS also improve the preparedness of an organization to give an explanation (...) and a justification to relevant stakeholders for its judgments, intentions, acts and omissions when appropriately called upon to do so. However, IAS also face a variety of problems impeding their potential to help address social and environmental issues. The contribution of the four articles in this special section is discussed in the context of standards’ problems and opportunities. The article closes by outlining a research agenda to further develop and extend the scholarly debate around IAS. (shrink)

ABSTRACT:A common complaint by academics and practitioners is that the application of international accountability standards (IAS) does not lead to significant improvements in an organization’s social responsibility. When organizations espouse their commitment to IAS but do not put forth the effort necessary to operationally enact that commitment, a “credibility cover” is created that perpetuates business as usual. In other words, the legitimacy that organizations gain by formally adopting the standards may shield the organization from closer scrutiny, thus (...) enabling rather than constraining the types of activities the standards were designed to discourage.There is a lack of research on why certain types of IAS are more prone than others to being decoupled from organizational practices. Applying a neo-institutional perspective to IAS, we theorize that the structural dimensions of the types of standards themselves can increase the likelihood of organizations adopting IAS standards in form but not in function. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

ABSTRACT:This paper analyzes how national institutional factors affect the adoption of the international environmental management standard ISO 14001, using a panel of 139 countries from 1996 to 2006. The analysis emphasizes that during the emerging phase of the standard, the potential lack of consensus within the constituents of the national institutional environment concerning the value of a new standard could send mixed signals to firms about the standard. The results show that in the early phase of adoption, regulative and (...) normative forces within the institutional environment can work against each other. Results also show that regulative or coercive forces play a relatively more important role in the early phase of adoption of the standard than in the subsequent phases of diffusion. In the later phases of diffusion of ISO 14001, normative forces, such as the diffusion of other management standards, as well as factors related to trade, play a more important role. Because of the similarities between environmental management standards and corporate social responsibility standards, this study can help identify some of the challenges for diffusion of ISO management standards in the area of social responsibility. (shrink)

The increasing use of transnational standard-setting bodies to address quality uncertainties and coordination issues across the global economy raises questions about how these bodies establish and maintain their legitimacy and accountability outside the sovereignty of democratic states. Based on a discussion of the legitimacy challenge posed by global governance, we provide an overview of mechanisms by which such bodies can defend their legitimacy claims and examine the actual mechanisms used by the International Accounting Standards Board (IASB). While the (...) IASB staked its initial credibility on technical competence and independence, it has increasingly emphasized due process norms in its claim for support. Our analysis evaluates the IASB due process against the cultural benchmarks established by domestic standard-setters in the USA and UK and against a normative model of procedural legitimacy. These comparisons help us to understand the modifications that were made in the hope of due process adding legitimacy to accounting standard-setting beyond the state. They also reveal the broader political context of competing legitimacy criteria that confronts transnational standard-setters. (shrink)

There is a lack of research on why certain international accountability standards (IAS) are more prone than others to being decoupled from organizational practices. Applying a neo-institutional theory perspective to IAS we theorize that the structural dimensions of the standards themselves can increase the likelihood of organizations adopting IAS standards in form but not in function.

This book explores how Cross-cultural research and relationships are unavoidable because of the current veracity of globalization and how all research methodologies and relationships are affected given the necessity of interpretation of data collected and differences in cultural values and philosophies in all areas of human activities.

A summary of the career of a Russian engineer who practiced a century ago in western Europe, as well as in Russia, provides an example of how ethical standards can influence practice across national boundaries. An examination of his career and his conception of engineering, of the evolution of engineering standards and codes, and of the process of formulating codes in particular instances explains how international standards can shape practice in an international context.

The literature presents a broad approach to Corporate Social Responsibility, which aggregates a diversity of issues, such as the environment, labor conditions, and human rights. We addressed the impact of increasing CSR demands during the internationalization of emerging market multinationals on one particular subject, animal welfare. This subject raises important ethical concerns, especially as we understand that animals are sentient beings. Through content analysis of annual reports, we tracked the evolution of AW-CSR activities throughout the internationalization of two large Brazilian (...) meat-processing multinationals as they accessed markets with complex AW regulations. We also synthetized findings on broiler chicken on-farm AW research in Brazil and conducted interviews to gauge the impact of CSR standards on animals. Our findings show that, although EMNs that enter developed markets engage with various standards, the impacts of standard enforcement on actual welfare are not straightforward and call for broader AW and animal ethics developments. Uneven results among AW criteria indicate that some aspects are prioritized over others. Furthermore, some actions of actors such as EMNs and low-tier suppliers seem to counterbalance the expected impact of normative pressures to change the lives of animals for the better. We conclude that AW standards may improve AW in emerging markets; but these standards do not appear to be sufficiently stringent, and require improvements to have a more significant positive impact. A major signal emerging from this research is the fundamental need to broaden the animal ethics debate regarding the use of animals to produce meat. (shrink)

Although inclusion in formal value chains extends the prospect of improving the livelihoods of rural small-scale producers, such a step is often contingent on compliance with internationally-promoted food safety standards. Limited research has addressed the challenges this represents for small rural producers who, grounded in culturally-embedded food safety conceptions, face difficulties in complying. We address this gap here through a multiple case study involving four public school feeding programs that source meals from local rural providers in the Bolivian Altiplan. (...) Institutional logics theory is used to describe public food safety regulations and to compare them to food safety conceptions in the local indigenous Aymara rural setting. We identify a value-based conflict that leads to non-compliance of formal food safety rules that jeopardizes the participation of small farmers in the market. These include: partial adoption of formal rules; selective adoption of convenient rules; and ceremonial adoption to avoid compliance. Decoupling strategies allow local actors to largely disregard the formal food safety regulations while accommodating traditional cultural practices and continuing to access the market. However, these practices put the long-term sustainability of the farmers’ participation in potentially favorable opportunities at risk. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

The recent proliferation of International Accountability Standards (IAS) has attracted significant academic interest, but the extent of their adoption and integration by global firms remains underinvestigated.Capitalizing on institutional theory and the typology of strategic responses to institutional pressures proposed by Oliver (Acad Manage Rev 16(1): 145-179, 1991), this article uses an interpretive research methodology to analyze a sample of MNC practitioners' views regarding IAS, and derive some insights in relation to expected patterns of strategic responses to these new (...) institutional pressures. The article also presents relevant remarks relating to the usefulness of institutional theory in the context of research relating to IAS. The findings suggest patterns of engagement combining elements of both conformity and resistance, although the answers correspond most closely to a decoupling or symbolic conformity strategic response. The findings are fleshed out and their implications delineated/assessed. (shrink)

The Report of the National Academy of Sciences Monitoring International Labor Standards: Techniques and Sources of Information shows that assessing compliance can be carried out in a thorough, transparent fashion, allowing alternative evaluators to identify where they disagree in assessment. Drawing on the Report and written by the Chair of the Committee that produced it, this paper offers a short overview of the principal challenges in assessing compliance with the ILO core labor standards, and offers a simple (...) framework for investigating compliance. The paper concludes with a discussion of the implications for trying to include labor standards in trade agreements. (shrink)

How do “international” epistemic communities shape regulatory contests between transnational firms and civil society organizations in the Global South? With the establishment of the World Trade Organization, member states committed to basing trade-restrictive national regulations on science-based “international” standards set by “international” standard-setting bodies. Yet we know little about how the WTO regime has shaped the operation of epistemic communities within standard-setting bodies and, in turn, how standard-setting bodies articulate with national policy-making processes in the Global (...) South. Building on work in the new political sociology of science, I argue that neoliberal globalization and the establishment of the WTO have created incentives for Western epistemic communities to at once cast themselves as “international” under the WTO regime and orient their scientific agendas toward the priorities of transnational firms. Moreover, this transformation of epistemic communities has created opportunities for transnational firms facing contentious policy environments in the Global South to effectively outsource regulatory decision-making to “international” epistemic communities that can claim legal status under the WTO regime. Empirically, I focus on the case of one Western epistemic community—the Association of Analytical Communities International—and its claim to epistemic jurisdiction over pesticide residue standards for soft drinks in India. (shrink)

In September 2010, the International Organization for Standardization adopted a new International Guidance Standard on Organizational Social Responsibility — ISO 26000. This Article, written by a participant in the process of developing the standard over a five-year period, considers the points of intersection between ISO 26000 and public policy, international law, democracy, and the role of the state. The Article is grounded in an analysis of the standard’s negotiating history. The concluding Part reflects on the implications of (...) these observed facts for the development of appropriate descriptive and normative theoretical frameworks and proposes three innovations that could underpin a less problematic relationship between ISO, public policy and the role of the state. (shrink)